Nonparametric Superposition to Predict Ropinirole Pharmacokinetics Data at Steady-state using Singledose Data
PRESENTED TO: BioPharma Services Inc.
PRESENTED BY: Z. Tayab, F. Trabelsi, J. He
PURPOSE
Nonparametric Superposition to Predict Ropinirole Pharmacokinetics Data at Steady-state using Singledose Data – The current EMA bioequivalence guideline states that steady-state studies are required for drugs which are extended modified release, or if a single dose study cannot be conducted in healthy volunteers due to tolerability reasons, and a single dose study is not feasible in patients. Ropinirole extended release tablets is an example of this type of drug. The prediction of ropinirole steady-state levels using single dose data will support the development of an optimal steady-state design.
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